title: Birch bark extract as therapy for chronic hepatitis C--a pilot study.
abstract: The hepatoprotective effect of birch bark extract (BBE) in patients with chronic hepatitis C (CHC) was studied. Forty-two patients with serologically confirmed chronic hepatitis C were treated for 12 weeks with 160 mg standardized BBE per day. The primary outcome parameter measured was the rate of alanine aminotransferase (ALT) normalization after 12 weeks. Secondary parameters included the course of ALT, aspartate aminotransferase (AST) levels, quantitative HCV RNA levels, subjective symptoms associated with CHC (fatigue, abdominal discomfort, depression, and dyspepsia), safety and compliance. The qualitative-quantitative analysis of BBE was made using high performance liquid chromatography to confirm the presence of 75% betulin and 3.5% betulinic acid. Significant differences in the mean ALT and HCV RNA levels were observed after 12 weeks of treatment. The level of ALT was decreased in 54.0% and normalized (p=0.046). HCV RNA was reduced in 43.2% (p=0.016). After 12 weeks of treatment, reports of fatigue and abdominal discomfort were reduced by 6-fold (p=0.028) and 3-fold (p=0.05), respectively. Dyspepsia was no longer reported (p=0.042) and the effect was significantly different from baseline. Because this study lacks a control group clinical relevance of the data can only be estimated in future by following controlled clinical trials.
authors.affiliation: Saint Petersburg State Medical Academy named after I.I. Mechnikov, 47, Piskarevsky pr., 195067 Saint Petersburg, Russia. spb.pharmacy@gmail.com
authors.forename: Alexander N
authors.initials: AN
authors.lastname: Shikov
authors.forename: Georgy I
authors.initials: GI
authors.lastname: Djachuk
authors.forename: Dmitry V
authors.initials: DV
authors.lastname: Sergeev
authors.forename: Olga N
authors.initials: ON
authors.lastname: Pozharitskaya
authors.forename: Elena V
authors.initials: EV
authors.lastname: Esaulenko
authors.forename: Vera M
authors.initials: VM
authors.lastname: Kosman
authors.forename: Valery G
authors.initials: VG
authors.lastname: Makarov
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000998:Antiviral Agents / Q000737:chemistry; D029662:Betula / Q000737:chemistry*; D015992:Body Mass Index; D004415:Dyspepsia / Q000188:drug therapy; D005221:Fatigue / Q000188:drug therapy; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D053978:Pentacyclic Triterpenes; D008517:Phytotherapy; D010865:Pilot Projects; D024301:Plant Bark / Q000737:chemistry; D010936:Plant Extracts / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D014315:Triterpenes / Q000737:chemistry / Q000627:therapeutic use; D055815:Young Adult; D000094062:Betulinic Acid
chemical_list: D000998:Antiviral Agents; D053978:Pentacyclic Triterpenes; D010936:Plant Extracts; D012367:RNA, Viral; D014315:Triterpenes; C002503:betulin; D000094062:Betulinic Acid